Laryngeal Cancer Clinical Trial
Official title:
Concomitant Chemotherapy AND Bcl-xL Inhibitor (AT-101) For Bio-selection For Organ Preservation In Patients With Advanced Laryngeal Cancer
Verified date | July 2023 |
Source | University of Michigan Rogel Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate a new treatment approach for adults with advanced laryngeal cancer: induction chemotherapy with platinum and docetaxel plus AT-101. AT-101 is an investigational drug for the treatment of advanced cancer. It is hoped that the combination of this chemotherapy regimen will allow cancer patients to keep their voice box and to improve/maintain voice-related quality of life. The ultimate goal of this study is to prevent the surgery to remove subjects voice box.
Status | Completed |
Enrollment | 55 |
Est. completion date | November 6, 2021 |
Est. primary completion date | November 6, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients must have pathologically confirmed, previously untreated, resectable, squamous cell carcinoma of the larynx or hypopharynx. - Disease must be Stage III or IV - Tumor must be potentially surgically resectable and curable with conventional surgery and radiation therapy - Patients must undergo pre-treatment endoscopic tumor staging and CT scanning - ECOG Performance status 0-1 - Adequate WBC (white blood cell), granulocyte and platelet counts - Creatinine clearance of = 60cc/min for cisplatin candidates and = 30 cc/min for carboplatin candidates - Adequate bilirubin, AST (aspartate aminotransferase), and ALT (alanine transaminase) function Exclusion Criteria: - Prior head and neck malignancy or history of other prior non-head and neck malignancy within the past 3 years - Prior head and neck radiation or prior chemotherapy. - Documented evidence of distant metastases - Active infection - Pregnancy or lactation - Any medical or psychiatric illness which in the opinion of the principal investigator would compromise the patient's ability to tolerate this treatment - Patients residing in prison - Patients with psychiatric/ social situations that would limit compliance with study requirements - Patients with Grade > 2 peripheral neuropathy - History of severe hypersensitivity reaction to docetaxel - Class 3 or 4 cardiac disease - Unstable angina or history of myocardial ischemia within prior 6 months - Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, ulcerative colitis, inflammatory bowel disease, partial or complete small bowel obstruction - Prior use of gossypol or AT-101, or known hypersensitivity to gossypol or AT-101 - Patients taking any other concurrent approved or investigational anti-cancer therapy |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan Rogel Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Patients Alive and Free From Indication for Laryngectomy Three Months Post Treatment | The primary clinical objective of this trial is to compare the larynx preservation rates in a treatment paradigm that uses induction chemotherapy plus AT-101 to select patients for either concurrent chemoradiation or surgery. Organ preservation rate, defined as alive and free from indication for laryngectomy three months post treatment, was chosen as the primary endpoint because it provides evidence to fully characterize clinically the effect of the treatment strategy | Up to 3 months after end of treatment | |
Primary | Progression-free Survival | Time from randomization to the time of first indication of local failure or metastases. Estimated non-parametrically using the Kaplan-Meier method. | Up to 3 years after randomization | |
Primary | Overall Response Rate (ORR) | ORR (Complete Response [CR] plus Partial Response [PR]) to induction chemotherapy with platinum and docetaxel plus AT-101 following one and/or two cycles in patients with advanced laryngeal cancer. | Up to approximately 60 days | |
Primary | Percentage of Patients Experiencing Grade 3 or Higher Adverse Events. | Toxicities will be evaluated using the Common Terminology Criteria for Adverse Events (CTCAE), version 3. | Up to 3 years after end of treatment | |
Secondary | Head and Neck Related Quality of Life (QOL) | University of Michigan Head and Neck Quality of Life Instrument (HN-QOL) will be administered prior to treatment (i.e. pre-induction chemotherapy) and at 6 months, 12 months, and 24 months (+/- 4 months) after completion of chemo-RT or surgery-RT (or surgery-chemoRT, as indicated). Scale is 0-100 with high scores indicating a better outcome. | Up to 28 months post treatment | |
Secondary | Voice Related QOL | The University of Michigan Voice Related Quality of Life Measure (V-RQOL) will be administered prior to treatment (i.e. pre-induction chemotherapy) and at 6 months, 12 months, and 24 months (+/- 4 months) after completion of chemo-RT or surgery-RT (or surgery-chemoRT, as indicated). Scale is 0-50 (10 items scale 1-5) with high scores indicating a worse outcome. | Up to 28 months post treatment | |
Secondary | Functional Assessment QOL | University of Michigan Head and Neck Quality of Life Instrument (HN-QOL) will be administered prior to treatment (i.e. pre-induction chemotherapy) and at 6 months, 12 months, and 24 months (+/- 4 months) after completion of chemo-RT or surgery-RT (or surgery-chemoRT, as indicated). Scale is 0-100 with high scores indicating a better outcome. EATING Domain is reported here as a functional assessment. | Up to 28 months post treatment |
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